Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia
M.D. Anderson Cancer Center
Summary
The goal of Phase 1 is to find the recommended dose of ziftomenib and olutasidenib in patients with relapsed/refractory AML that has a mutation in the NPM1 and IDH1 genes. The goal of Phase 1b is to learn if the recommended dose of ziftomenib and olutasidenib found in Phase 1 can help to control the disease. The safety and effects of this combination will also be studied in both parts.
Description
Primary Objectives: * Phase 1: To determine the safety and tolerability and recommended phase 2 dose (RP2D)) of ziftomenib and olutasidenib in adult patients with R/R NPM1 and IDH1 co-mutated AML * Phase 1b: To determine the preliminary efficacy of combination treatment as reflected by the composite remission rate (CRc=CR+ CRi +CRh) of ziftomenib and olutasidenib in adult patients with R/R NPM1 and IDH1 co-mutated AML Secondary Objectives: * To determine the overall response rate (ORR) including composite remission rate (CRc), partial remission (PR), and morphologic leukemia free state (MLF…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age \> 18 years 2. Diagnosis of relapsed or refractory AML (including biphenotypic or bilineage leukemia) as defined by ≥ 5% marrow blasts; patients with isolated extramedullary AML without marrow involvement are not eligible 3. AML disease must be characterized by IDH1 and NPM1 co-mutations as determined by local molecular testing (next generation sequencing, PCR) 4. Eastern Cooperative Oncology Group (ECOG) Performance Status \</=2 5. Adequate renal function with CrCl ≥30 ml/min to be calculated using Cockroft Gault formula 6. Adequate hepatic function (total bilirubi…
Interventions
- DrugZiftomenib
Given by mouth
- DrugOlutasidenib
Given by mouth
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas